DEVICE: Marina Medical (00840306830686)

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Device Record History
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Device Identifier (DI) Information
Marina Medical
040-070RG
In Commercial Distribution
040-070RG
MARINA MEDICAL INSTRUMENTS, INC.
00840306830686
GS1

1
011442279 *Terms of Use
Scalpel Handle #3, GOLD FINISH, Round Handle, 14.5cm for Blade size 10-18
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
37445 Manual scalpel blade, single-use
An interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GES BLADE, SCALPEL
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 14.5 Centimeter
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Device Record Status
57e718d9-56d8-4623-90b5-2bab37fba747
January 22, 2025
2
July 19, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(954)924-4418
enrico@marinamedical.com
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